UK-based biopharmaceutical company Mereo BioPharma has announced that its BPS-804 drug has been accepted to participate in the European Medicines Agency’s (EMA) adaptive pathways programme.
As part of the adaptive pathways approach, EMA aims to improve timely access for patients to new medicines, primarily in areas of high medical need.
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Mereo is developing the new BPS-804 drug to treat osteogenesis imperfecta (OI).
The product received orphan drug designation from both the European Commission (EC) and the US Food and Drug Administration (FDA).
Mereo BioPharma CEO Dr Denise Scots-Knight said: “Osteogenesis imperfecta is a serious, debilitating and painful disease where we believe BPS-804 could reduce fractures and improve quality of life in OI patients.
“We are on track to initiate a phase 2b trial for BPS-804 in H1 2017 and as part of the adaptive pathways we have the potential to bring this important therapy to patients sooner.”
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By GlobalDataOI is a rare genetic disorder characterised by fragile bones prone to easy breakage. It currently has no EMA or FDA approved treatments.
BPS-804 will work by inhibiting sclerostin, which restrains the activity of bone-forming cells known as osteoblasts.
By blocking sclerostin, the drug is believed to induce or increase osteoblast function and maturation, increasing bone formation and reducing bone resorption. This results in the reduction of bone fragility and fractures in OI patients.
Mereo initiated a Phase II study with acumapimod and a Phase IIb study with BGS-649 during the first half of last year.
The first pivotal trial for BPS-804 is expected to begin during the first half of this year.
People with OI often suffer from muscle weakness, hearing loss, fatigue, joint laxity, curved bones, scoliosis, and short stature.
